The Cost-effectiveness Analysis of a Wearable Device-based Assisted Rehabilitation System for Discharged Patient With Stroke
Sponsor study identifier
interventional
140
0 countries
N/A
Study Start
November 2015
Actual (reported)Primary Completion
November 2017
Actual (reported)Study Completion
April 2018
Actual (reported)Multidisciplinary rehabilitation facilitates functional recovery after stroke, and adherence to rehabilitation guidelines is associated with improved outcomes. We assessed the efficacy of a wearable device-assisted rehabilitation system in addition to conventional therapy compared to conventional therapy alone. A total of 127 eligible acute stroke inpatients were enrolled. There were 76 males (59.8%). The mean age of the participants was 57.45 years; 63 and 64 participants were randomized to the WG and CG, respectively. Both groups showed significant improvements in mRS scores at 90 days (WG: -0.68 \[95% confidence interval (CI), -0.94 to -0.42\]; CG: -0.56 \[95% CI, -0.74 to -0.38\]; P\<0.0001), but only the WG had significant improvements between 30 and 90 days (-0.36; 95% CI, -0.72, -0.007; P=0.049). Both groups had significant improvements in secondary outcomes at 90 days, but there was no difference between groups.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2015
Actual (reported)November 2017
Actual (reported)April 2018
Actual (reported)July 31, 2021
Actual (reported)August 9, 2021
Actual (reported)The primary outcome measure was changed in mRS, which was defined by scores of 0 to 4 on the modified Rankin scale
The primary outcome measure was changed in mRS, which was defined by scores of 0 to 4 on the modified Rankin scale, a global seven-level measure of functioning in which scores of 0 or 1 indicate a good outcome with no or minimal neurologic symptoms, scores of 2 to 5 indicate a poor outcome with increasing degree of disability, and 6 indicates death.
Baseline, 30 days and 90 days
Change in Barthel Index (BI) at 30 days, 90 days
Baseline, 30 days and 90 days
Change in upper limb (UL) function (Stream Wolf Motor Function Test)
Baseline, 30 days and 90 days
Change in functional status (Functional Independence Measure)
Baseline, 30 days and 90 days
Change in static and dynamic balance ability (Berg balance scale)
Baseline, 30 days and 90 days
Mobile device-assisted rehabilitation
In-person therapist-supervised rehabilitation
A Wearable Device-Based Assisted Post-Stroke Rehabilitation system
In-person therapist-supervised rehabilitation
Ho HJ, Wu LC, Wu EH, Lee SF, Lee TH, Chiang SH, Chen CH, Chen HY, Pan SJ, Chen YW; WEAR-Stroke Study Group. Improving patient outcomes in acute and subacute stroke using a wearable device-assisted rehabilitation system: a randomized controlled trial. J Int Med Res. 2024 Oct;52(10):3000605241281425. doi: 10.1177/03000605241281425.
140 participants (actual enrollment reported by the registry).
First Submitted
July 31, 2021
First Posted
August 9, 2021
Study Start
November 2015
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
November 2017
Actual (reported)Study Completion
April 2018
Actual (reported)Last Updated
May 17, 2022
Record last verified: 2022-05
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Source: ClinicalTrials.gov.
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